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510(k) Data Aggregation
K Number
K001593Manufacturer
Date Cleared
2000-06-14
(22 days)
Product Code
Regulation Number
878.4400Type
SpecialReference & Predicate Devices
N/A
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Device Name :
MODIFICATION TO STATSIGN SALINE ELECTROLYTE GEL, GRAHAM-FIELD SALINE ELECTROLYTE GEL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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